药品名称DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号019950产品号003
活性成分FLUCONAZOLE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格200MG/100ML (2MG/ML)
治疗等效代码AP参比药物
批准日期1992/09/29申请机构PFIZER INC
化学类型New dosage form审评分类
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
019950062APLabel2014/03/25下载
019950062APLetter2014/03/25下载
019950061APLabel2013/09/17下载
019950061APLetter2013/09/17下载
019950059APLetter2011/11/21下载
019950059APLabel2011/11/21下载
019950057APLetter2011/04/29下载
019950057APLabel2011/04/29下载
019950056APLabel2011/06/06下载
019950056APLetter2011/06/08下载
019950053APLetter2010/08/10下载
019950053APLabel2010/08/10下载
019950043APLetter2008/04/04下载
019950043APLabel2008/04/16下载
019950039APLetter2004/03/28下载
019950039APLabel2004/04/05下载
019950037APLetter2004/10/08下载
019950037APLabel2004/10/08下载
019950033APLetter2004/10/08下载
019950033APLabel2004/10/08下载
019950031APLabel2004/10/08下载
019950031APLetter2004/10/08下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
019950065AP2015/06/01Manufacturing Change or Addition
019950063AP2014/07/28Manufacturing Change or Addition
019950062AP2014/03/24Labeling Revision
019950061AP2013/09/13Labeling Revision
019950059AP2011/11/16Labeling Revision
019950057AP2011/04/26Labeling Revision
019950056AP2011/06/06Labeling Revision
019950053AP2010/08/05Labeling Revision
019950043AP2008/03/31Labeling Revision
019950039AP2004/03/24Labeling Revision
019950037AP2004/10/07Labeling Revision
019950034AP2002/08/07Labeling Revision
019950033AP2004/10/07Labeling Revision
019950032AP2001/03/05Control Supplement
019950031AP2004/10/07Labeling Revision
019950030AP1999/09/29Manufacturing Change or Addition
019950029AP1999/09/29Manufacturing Change or Addition
019950028AP1999/02/22Labeling Revision
019950027AP1998/02/13Manufacturing Change or Addition
019950026AP1997/08/05Labeling Revision
019950025AP1997/02/19Labeling Revision
019950024AP1996/08/06Labeling Revision
019950022AP1996/07/23Labeling Revision
019950021AP1995/12/22Control Supplement
019950020AP1995/03/20Control Supplement
019950019AP1995/03/09Control Supplement
019950018AP1994/06/30Labeling Revision
019950017AP1994/08/22Control Supplement
019950016AP1994/11/23Patient Population Altered
019950012AP1994/07/08Package Change
019950011AP1993/06/22Manufacturing Change or Addition
019950010AP1993/10/13Labeling Revision
019950009AP1993/02/10Control Supplement
019950008AP1993/06/14Control Supplement
019950007AP1993/10/13Labeling Revision
019950004AP1993/12/30New or Modified Indication
019950003AP1993/10/13Labeling Revision
019950002AP1992/09/29Control Supplement
019950000AP1990/01/29Approval